A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

Gastric Cancer Clinical Trial

— JOSHUA  

Official title:

An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461057
• Other study ID #: BP27836
• Status: Completed
• Phase: Phase 2
• Start date: December 6, 2011
• Est. completion date: October 31, 2017

Study information

• Verified date: July 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2017
• Est. primary completion date: March 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants, greater than or equal to (>=) 18 of age

• Adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy

• Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1

• HER2-positive tumor

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Life expectancy of at least 3 months

Exclusion Criteria:

• Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or neoadjuvant therapy at least 6 months before enrollment in the study)

• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome

• Active (significant or uncontrolled) gastrointestinal bleeding

• Abnormal laboratory values

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Capecitabine
1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle
• Cisplatin
80 mg/m2 on Day 1 of each cycle
• Pertuzumab
loading dose of 840 mg, then 420 mg once every three weeks
• Pertuzumab
840 mg once every three weeks
• Trastuzumab
loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	UZ Leuven Gasthuisberg	Leuven
Czechia	Masaryk Memorial Cancer Institute; Oncological Clinic	Brno
Czechia	Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc; Onkologicka klinika	Olomouc
Czechia	Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni	Praha 5
Czechia	University Hospital Na Bulovce; Institut of Radiation Oncology	Praha 8
France	Hopital Morvan	Brest
France	CRLCC Val dAurelle Paul Lam	Montpellier cedex 5
France	Hopital Robert Debre; DERMATOLOGIE	Reims
Germany	Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.	Berlin
Germany	Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie	Braunschweig
Germany	Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie	Frankfurt
Germany	Klinikum Mannheim III. Medizinische Klinik	Mannheim
Italy	Campus Universitario S.Venuta; Centro Oncologico T.Campanella	Catanzaro	Calabria
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2	Milano	Lombardia
Italy	A.O. Universitaria Pisana; Oncologia	Pisa	Toscana
Korea, Republic of	Asan Medical Center; Medical Oncology	Seoul
Korea, Republic of	Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology	Seoul
Korea, Republic of	Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology	Seoul
Netherlands	Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde	Maastricht
Spain	Hospital del Mar; Servicio de Oncologia	Barcelona
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Italy,  Korea, Republic of,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL)		Day 43
Primary	Number of Participants With Adverse Events (AEs)	An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.	From randomization of first participant to end of study (approximately 6 years)